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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04607837




Registration number
NCT04607837
Ethics application status
Date submitted
23/10/2020
Date registered
29/10/2020
Date last updated
20/09/2021

Titles & IDs
Public title
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
Secondary ID [1] 0 0
2020-003507-34
Secondary ID [2] 0 0
APD334-210
Universal Trial Number (UTN)
Trial acronym
GLADIATOR UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo

Experimental: Etrasimod 2 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Achieving Clinical Remission as Assessed by Total Mayo Clinic Score
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of Participants With Reduction From Baseline in Both Endoscopic Score and Rectal Bleeding or in Both Endoscopic Score and Stool Frequency
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of Participants Achieving Endoscopic Improvement
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of Participants With Histologic Response as Assessed by Robarts Histopathology Index Score
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of Participants With a Clinical Response as Assessed by Total Mayo Clinic Score
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of Participants Achieving Symptomatic Remission
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Number and Severity of Adverse Events - Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Timepoint [6] 0 0
Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period)

Eligibility
Key inclusion criteria
- Diagnosed with Ulcerative Colitis (UC) = 3 months prior to screening

- Active UC confirmed by endoscopy

- Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic
score = 1

- Received a surveillance colonoscopy within 12 months before baseline
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe extensive colitis

- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a
fistula consistent with Crohn's disease

- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

- Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks
prior to or after screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Coastal Digestive Health Pty Ltd. - Maroochydore
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Belgium
State/province [16] 0 0
Roeselare
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Ruse
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sliven
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Veliko Tarnovo
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Czechia
State/province [22] 0 0
Kralov
Country [23] 0 0
Czechia
State/province [23] 0 0
Olomouc
Country [24] 0 0
Czechia
State/province [24] 0 0
Ostrava - Poruba
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 9
Country [26] 0 0
Czechia
State/province [26] 0 0
Slany
Country [27] 0 0
France
State/province [27] 0 0
Clermont-Ferrand Cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Grenoble
Country [29] 0 0
France
State/province [29] 0 0
Nantes Cedex 1
Country [30] 0 0
France
State/province [30] 0 0
Nice Cedex 3
Country [31] 0 0
France
State/province [31] 0 0
Rennes
Country [32] 0 0
Germany
State/province [32] 0 0
Remscheid
Country [33] 0 0
Hungary
State/province [33] 0 0
Heves
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Debrecen
Country [36] 0 0
Israel
State/province [36] 0 0
Holon
Country [37] 0 0
Israel
State/province [37] 0 0
Jerusalem
Country [38] 0 0
Israel
State/province [38] 0 0
Nahariya
Country [39] 0 0
Italy
State/province [39] 0 0
Vicenza
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gangwon-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Gyeongsangbuk-do
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Poland
State/province [43] 0 0
Dolnoslaskie
Country [44] 0 0
Poland
State/province [44] 0 0
Lodzkie
Country [45] 0 0
Poland
State/province [45] 0 0
Malopolskie
Country [46] 0 0
Poland
State/province [46] 0 0
Mazowieckie
Country [47] 0 0
Poland
State/province [47] 0 0
Weilkopolski
Country [48] 0 0
Poland
State/province [48] 0 0
Wielkopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Zachodnipomorskie
Country [50] 0 0
Portugal
State/province [50] 0 0
Porto
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Nizhniy Novgorod
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Omsk
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Samara
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Stavropol
Country [55] 0 0
Spain
State/province [55] 0 0
Alicante
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Ukraine
State/province [57] 0 0
Ivano-Frankivsk
Country [58] 0 0
Ukraine
State/province [58] 0 0
Kharkiv
Country [59] 0 0
Ukraine
State/province [59] 0 0
Kyiv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Uzhgorod
Country [61] 0 0
Ukraine
State/province [61] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arena Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective
treatment for moderately active ulcerative colitis in adult participants.
Trial website
https://clinicaltrials.gov/show/NCT04607837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arena CT.gov Administrator
Address 0 0
Arena Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arena CT.gov Administrator
Address 0 0
Country 0 0
Phone 0 0
+1 855-218-9153
Fax 0 0
Email 0 0
ct.gov@arenapharm.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04607837